510(k) Report

510(k) · Cleared

Cleared

Preview Anterior Cervical Plate System

K062371510(k) TraditionalCleared Dec 4, 2006112-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alphaspine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 4, 2006 after a 112-day review. The FDA summary names no predicate by number. 3 later devices descend from it.

Decided
Dec 4, 2006
Review
112 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK062371 Preview Anterior Cervical Plate SystemAlphaspine, Inc. · 2006
  2. Descendant · cites it directly · 1 of its ownK223627 PreView-III™ Anterior Cervical Plate SystemNexus Spine, LLC · 2023
  3. Descendant · 2 generations on · 0 of its ownK261279 DeltaNEC Interbody SystemNexus Spine · 2026
  4. Descendant · cites it directly · 0 of its ownK073500 Active Anterior Cervical Plate SystemSanacor · 2008

Most influential descendants

Showing 3 of 3 · See all
  • K223627PreView-III™ Anterior Cervical Plate SystemNexus Spine, LLC · 2023 · cites it directly1descendant
  • K261279DeltaNEC Interbody SystemNexus Spine · 2026 · 2 generations on0descendants
  • K073500Active Anterior Cervical Plate SystemSanacor · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062371Preview Anterior Cervical Plate SystemAlphaspine, Inc.2006—
+1K223627PreView-III™ Anterior Cervical Plate SystemNexus Spine, LLC2023—
+2K261279DeltaNEC Interbody SystemNexus Spine2026—
+1K073500Active Anterior Cervical Plate SystemSanacor2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
202310
202610
FIG. 1 — Lineage of K062371, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K223627PreView-III™ Anterior Cervical Plate SystemNexus Spine, LLC20231
K073500Active Anterior Cervical Plate SystemSanacor20080

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K223627 (Nexus Spine, LLC, 2023) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The PreView Tm Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft, The implants are attached to the anterior cervical spine (C2-Tl) with remhoval of the implants after the attainment of a solid fusion mass. The PreView TM Anterior Cervical Plate System is intended for use under the following indications: * Degenerative disc disease…

Read the full statement (116 words)

The PreView Tm Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft, The implants are attached to the anterior cervical spine (C2-Tl) with remhoval of the implants after the attainment of a solid fusion mass. The PreView TM Anterior Cervical Plate System is intended for use under the following indications:

* Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

* Spondylolisthesis

: Trauma (i.e., fracture or dislocation)

· Spinal stenosis

1Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

* Tumor

*Pseudoarthrosis

* Failed previous fusion

Indications for use as stated in the FDA summary.

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K062371 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062371: Preview Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062371

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026